Articles

U.S. v. Caronia: What are the Implications?

March 15, 2013

Articles

U.S. v. Caronia: What are the Implications?

March 15, 2013

This article appeared in Pharmaceutical Compliance Monitor, March 15, 2013, and is reproduced with permission.

Alfred Caronia was a pharmaceuticals sales representative for Orphan Medical who, together with a physician in Orphan’s speaker program, promoted the drug Xyrem for off-label uses. Xyrem, known as the date rape drug, is approved for treatment of narcolepsy. Caronia and the physician were caught on tape promoting its use for treatment of insomnia, fibromyalgia, restless legs, Parkinson’s disease, and multiple sclerosis, and in unauthorized patient populations. Orphan and the physician pled guilty. After a trial on the merits, Caronia was acquitted of misbranding, but convicted of conspiracy to introduce a misbranded drug into interstate commerce in violation of 21 U.S.C. §§ 331(a) and 333(a) (2) of the Federal Drug and Cosmetic Act (“FDCA”).

On December 3, 2012, the Second Circuit Court of Appeals overturned Caronia’s conviction, citing his first amendment rights. It declared, unequivocally, that the government “cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA-approved drug.” Not surprisingly, this decision has been widely hailed as a “victory for free speech.” At the same time, the department of justice has declared that the decision will not significantly affect its prosecutions for misbranding. What implications, if any, will the Court’s decision in U.S. v. Caronia have?